After speaking with five ethics experts for this story, it appears Zhang’s violations — and what happened after they were discovered — are symptomatic of larger problems impacting the field of human subject research in the U.S. Those include patchwork oversight and poor communication between watchdog agencies, a lack of transparency and dialogue with the public, and a combination of money and prestige that sometimes safeguard an institution’s reputation more than patient welfare.

“Both from a scientific standpoint and ethical human subjects standpoint, not complying with the enrollment criteria is a big deal,” Carome said, calling the guidelines “crucial in terms of ensuring that human subjects are protected.”

The San Diego VA, shown on Nov. 15, 2018, provides services to the nearly quarter-million veterans in San Diego and Imperial counties, and has one of the largest research programs in the national VA network. (Megan Wood)

But, she said, “If there are active studies and participants are in danger, the confidentiality is out the window.”

Symptoms of a larger problem

Picture the framework for protecting research subjects as a house.

The foundation consists of a study, planned with sound scientific and ethical principles, and a responsible, ethical researcher. If and when things go wrong or change, they are communicated and addressed immediately. That didn’t happen in this case.

Institutional review boards, the next floor up, are often composed of expert volunteers who spend countless hours poring over hundreds of pages of research protocols, guidelines and regulations while also working their regular jobs. They rely on researchers to keep them updated, alert them to problems and speak the truth, but they may also have the power and responsibility to audit ongoing studies. It’s often a proactive system, but it wasn’t in Zhang’s case.

Problems with internal probes

An opinion article published by three ethics experts last year in The Journal of the American Medical Association said when internal investigations are completed, the reports are often not standardized, not peer reviewed, have limited oversight and contain conflicts of interest. “Even when institutions act, the information they release to the public is often limited and unhelpful,” they wrote.

Academic investigations – at least in California – are kept far from Google’s reach, and typically require a public records request and the knowledge they exist. The same goes for institutional review board investigations, reviews and audits.

And none of these systems communicate with each other in any meaningful way.

But even then, Springs said, it doesn’t always “turn into constructive discussion and dialogue around how we can fix it.”

Audits like Zhang’s are often unintelligible to the community, to patients enrolled and even to academics, even though they are the people who should be providing feedback and criticism, she said.

“These are opportunities where we can actually promote transparency,” she said, “and say, ‘Hey, this is what happened. This is how we approached it,’ and model effective dialogue with communities on how we can work better on this.

Correction: April 24, 2019 An earlier version of this story cited a 2017 industry publication that said the Office of Research Integrity had gone a year without making a research misconduct finding. Since the story published, the office has clarified that it went nine months and 21 days without a finding of research misconduct between 2016 and 2017.

About Brad Racino:

Brad Racino is a senior investigative reporter and assistant director at inewsource. To contact him with tips, suggestions or corrections, please email bradracino [at] inewsource [dot] org. You can contact him securely on Signal (845-553-4170).